Activites

• 1995/02/15 Final act published in Official Journal
  • Regulation 1995/297
  • OJ L 035 15.02.1995, p. 0001
• 1995/02/10 End of procedure in Parliament
• 1995/02/10 Act adopted by Council after consultation of Parliament
• 1995/02/03 Modified legislative proposal published
  • COM(1995)0027 summary

    The modified proposal incorporates Parliament's amendment which provides for estimates concerning revenues obtained from fees collected for the following financial year to be included in the annual estimate adopted by the Agency's Management Board under the provision of Article 57 (5) of Regulation No 2309/93. In addition, the proposal partly incorporates the amendment which provides for any Agency budget surplus to be considered under the Community budget, by proposing that a clause providing for these surplus amounts to be deducted from the Community contribution be included in the system. However, the Commission rejected those amendments which used the procedure under Article 189B of the Treaty for introducing any modifications to the regulation. �

• 1995/01/19 Decision by Parliament, 1st reading/single reading
  • T4-0012/1995 summary

    In adopting the HAUG report, Parliament approved the regulation on fees payable to the European Agency for the Evaluation of Medicinal Products. In its amendments Parliament stated that: - fees should constitute Community resources and any surplus should be assigned to the Community budget; - the Agency's annual estimate should include figures relating to fees for the following financial year; - the codecision procedure (Article 189B) should be applied to the modification of the fees system. �

• 1995/01/18 Debate in Parliament
• #1815
• 1994/12/08 Council Meeting
  • 1815
• 1994/12/05 Vote in committee, 1st reading/single reading
  • A4-0101/1994
• 1994/09/30 Committee referral announced in Parliament, 1st reading/single reading
• 1994/05/27 Legislative proposal published
  • COM(1994)0167 summary

    From 1995, the European Agency for the Evaluation of Medicinal Products would be called upon to examine requests for authorisation to market medicinal products from pharmaceutical companies, which would result in the collection of fees to provide revenue for the Agency's budget. This proposal for a regulation aimed to lay down the structure and the amount of fees paid by undertakings for the examination and revision of Community authorisations to market medicinal products and other services provided by the Agency. According to the proposal, an undertaking should pay a basic Community fee of ECU 200 000 for medicinal products for human use and ECU 100 000 for veterinary medicinal products with a view to obtaining an authorisation to market the said products as required by the centralised procedure. The proposal also provided for a number of other fees: - a reduced fee for applications which did not have to be supported by a full dossier (ECU 100 000 for products for human use; ECU 50 000 for veterinary products); - an extension fee when the applicant wished to extend the applications made for the same medicinal product (ECU 40 000 for products intended for human use; ECU 20 000 for veterinary products); -a variation fee for minor administrative modifications of type I, which was fixed at ECU 5 000, and a variation fee for complex modifications of type II, which was fixed at ECU 40 000 for medicinal products for human use and at ECU 20 000 for veterinary products; - a renewal fee which was charged for the obligatory five-yearly renewal of the Community marketing authorisation (ECU 40 000 for products for human use; ECU 20 000 for veterinary products); - a flat-rate fee of ECU 10 000 for inspections which were undertaken subsequent to the issuing of a marketing authorisation, at the request of, or in the interest of, its holder; -a fee which was charged for the Agency's arbitration services in the event of disagreement between Member States as to the authorisation of a medicinal product in accordance with the decentralised procedure (ECU 40 000 for medicinal products for human use; ECU 20 000 for veterinary products). In exceptional circumstances - medicinal products treating a limited number of patients with a rare disease, SMEs, imperative reasons of public health - waivers and fee reductions could be granted. �

Documents

• Legislative proposal published: COM(1994)0167
• Committee report tabled for plenary, 1st reading/single reading: A4-0101/1994
• Debate in Council: 1815
• Decision by Parliament, 1st reading/single reading: T4-0012/1995
• Modified legislative proposal published: COM(1995)0027
• : Regulation 1995/297
• : OJ L 035 15.02.1995, p. 0001

History

(these mark the time of scraping, not the official date of the change)